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IRCT20190306042943N2 IRCT 2019-05-02 Tabib Daru Dez. Study on the effect of oat galls in vaginal candidiasis A comparative study on the effect of herbal vaginal suppository containing oat gall extract and Clogin vaginal suppository in treatment of vaginal candidiasis 2019-05-22 anticipated 55 Complete https://irct.ir/trial/38096 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This is a single-center randomized, double-blind clinical trial study. In the present study, married women aged between 18 to 44 years old, with symptoms of vaginal candidiasis are recruited for primary evaluation. After diagnosis of vaginal candidiasis, the participants will receive Clogin (1% Clotrimazole) vaginal suppository or oat gall vaginal suppository which are coded as "A" and "B" by the pharmacologist, and researchers and the participants are blinded about the composition of medications. Excel Randomization scale will be used to devote participants for treating by medications coded as "A" or "B" . After data analysis, and opening the codes, the participants who were treated by Clogin (1% Clotrimazole) vaginal suppository would be considered as the control group and the the participants who were treated by oat gall vaginal suppository would be considered as the intervention group (55 person in each group), Blinding description: Clogin and Oat gall Suppository are made similarly and then coded as "A" and "B" by the pharmacologist. So, the clinician, researchers and the participants are blinded about the composition of medications (Double blind) until the opening the codes after data analysis. 3 Vaginal Candidiasis. Intervention 1: The control group: The 55 subjects in this group will be treated by Clogine suppository containing 1% clotrimazole, one suppository for 7 nights. The participants will complete the demographic and reproductive questionnaire. Then two checklists; including 1) checklist of symptoms of vaginal candidiasis and 2) Checklist of signs of vaginal candiasis; will be completed twice, first: with initiating of treatment and second: 7 days following treatment completion. Also, they will complete the form for assessing the side efects of the medications after treatment. Intervention 2: The intervention group: The 55 subjects in this group will be treated by vaginal herbal suppository containing oat gall extract one suppository for 7 nights. The participants will complete the demographic and reproductive questionnaire. Then two checklists; including 1) checklist of symptoms of vaginal candidiasis and 2) Checklist of signs of vaginal candiasis; will be completed twice, first: with initiating of treatment and second: 7 days following treatment completion. Also, they will complete the form for assessing the side efects of the medications after treatment. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no furthur information
public Mohaddese Mahboubi
Homa Building, Motahari Street, Kashan, Iran
Kashan Iran (Islamic Republic of) 8715115815 +98 31 5554 1000 mahboubi1357@yahoo.com Tabibdaru scientific Masoumeh Simbar
Midwifery and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Cross of Vali-Asr and Hashemi Rafsanjani Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran
tehran Iran (Islamic Republic of) 1996835119 +98 21 8865 5376 msimbar@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Married women aged between 18 to 44 years Old non- pregnant, non-breastfeeding, non- menopaused No vaginal bleeding Not taking any vaginal cream or suppository medications during the previous 48 hours not taking any antibiotics or antifungal medications for vaginitis during the previous 2 weeks not taking any corticostroids during the previous 2 weeks Patient with vaginal candidiasis No history of chronic diseases 18 years 44 years Female Existance of other vaginal infections Pregnancy during the study period Participation in another trial Occurrence of side effects N77.1 Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere Treatment - Drugs Treatment - Drugs The control group: The 55 subjects in this group will be treated by Clogine suppository containing 1% clotrimazole, one suppository for 7 nights. The participants will complete the demographic and reproductive questionnaire. Then two checklists; including 1) checklist of symptoms of vaginal candidiasis and 2) Checklist of signs of vaginal candiasis; will be completed twice, first: with initiating of treatment and second: 7 days following treatment completion. Also, they will complete the form for assessing the side efects of the medications after treatment. The intervention group: The 55 subjects in this group will be treated by vaginal herbal suppository containing oat gall extract one suppository for 7 nights. The participants will complete the demographic and reproductive questionnaire. Then two checklists; including 1) checklist of symptoms of vaginal candidiasis and 2) Checklist of signs of vaginal candiasis; will be completed twice, first: with initiating of treatment and second: 7 days following treatment completion. Also, they will complete the form for assessing the side efects of the medications after treatment. Symptoms of vaginal candidiasis (including: pruritus, vaginal soreness, dyspareunia, external dysuria, and abnormal vaginal discharge). Timepoint: Before intervention and 7 days after intervention. Method of measurement: Completing the checklist to assess the symptoms vaginal candidiasis and then comparing the frequency of the Symptoms of vaginal candidiasis within and between two groups of treatment. 2) Signs of vaginal candiasis (Including; vaginal erythema, excoriations, thick white adherent discharge). Timepoint: Before intervention and 7 days after intervention. Method of measurement: Completing the checklist to assess the Signs of Vaginal Candidiasis following vaginal examination and observation. Then comparing the frequency of the signs of vaginal candidiasis within and between two groups of treatment. The possible side defects of the medications after treatment. Timepoint: Before intervention and 7 days after intervention. Method of measurement: Completing the checklist to assess the possible side effects of the medications and then comparing the frequency of the side effects within and between two groups of treatment. Tabib Daru Dez. Approved 2018-12-03 National Ethics Committee on Biological Research Shahid Beheshti Medical university School of Nursing & Midwifery, Vali Asr Ave., Niayesh Cross Road, Niayesh Complex, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)